At-Home Genital Nerve Stimulation for SCI Bowel

Официальное название

At-Home Feasibility Trial of Genital Nerve Stimulation to Modulate Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury

Обзор

The purpose of this study is to test whether electrical stimulation of the skin in the pelvic area (near the genitals) can reduce the reflexes that cause bowel accidents in people with spinal cord injuries. Current bowel treatments either involve diet and medications or surgery. This study will evaluate whether electrical stimulation can be an alternate option for bowel management. Researchers will: * Use an FDA approved Transcutaneous Electrical Nerve Stimulation (TENS) device off-label * Compare a target stimulation level to a placebo stimulation level Participants will: * Use electrical stimulation on the skin in the pelvic area for 6-8 hours each day for 4 weeks at home * Visit the research center 3 times to participate in exams and answer questions * Keep a daily diary of their bowel symptoms and stimulation times

Подробное описание

The objective of this proposal is to determine how genital nerve stimulation (GNS) acutely modulates neurogenic bowel dysfunction (NBD) in individuals with different severities of spinal cord injury (SCI) and to determine the key study design and methodology parameters of daily at-home administration of GNS. This study will determine the feasibility of daily application of GNS as an intervention for NBD. Key feasibility measures related to dosage and adherence will be evaluated.

Вмешательства

• Устройство Genital nerve stimulation
  Genital nerve stimulation (GNS) will be administered via non-invasive surface skin electrodes. In men, two surface electrodes (1 cm diameter) will be placed on the dorsum of the penile shaft 2 cm apart. In women, one surface electrode will be placed near the clitoris and a second surface electrode will be placed on the labia majora or inner thigh. The electrodes will be connected to an electrical stimulator device.

Первичные конечные точки

• The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD. [Срок оценки: From baseline to the end of 6 weeks]
• The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD. [Срок оценки: From baseline to the end of 6 weeks]
• The primary endpoint will be the feasibility of daily application of GNS as an intervention for NBD. [Срок оценки: From baseline to the end of 6 weeks]

Вторичные конечные точки (7)

• Anorectal Manometry (ARM) [Срок оценки: From baseline to the end of 6 weeks]
• Clinical exam [Срок оценки: From baseline to the end of 6 weeks]
• Bowel diary [Срок оценки: From baseline to the end of 6 weeks.]
• Stimulation diary [Срок оценки: From baseline to the end of 6 weeks.]
• International SCI (ISCI) Bowel Function (BF) Basic Dataset (BDS) version 2.1 [Срок оценки: From baseline to the end of 6 weeks.]
• SCI-QoL Bowel Management Difficulties (SCI-QoL BMD) [Срок оценки: From baseline to the end of 6 weeks.]
• SCI Common Data Elements (CDEs) [Срок оценки: At baseline.]

Критерии участия

Критерии включения

• Traumatic SCI.
• Minimum of 6 months' post-injury.
• Aged 18 years and older.
• Neurological level of injury T12 or higher and AIS grade A-D, as defined by the ISNCSCI.
• Score of 14 or higher on the ISCI BF BDS v2.1.
• Response to genital nerve stimulation able to be elicited upon screening.
• Able to understand and provide informed consent.

Критерии исключения

• Currently enrolled in another functional electrical stimulation (FES) research trial.
• Females who are pregnant or planning to become pregnant in the duration of the trial (identified by self-report).
• Presence of a cardiac pacemaker, implanted defibrillator, or other implanted functional electrical stimulation device if, upon clinical evaluation, it may have an interaction with GNS.
• In the judgment of the PI and Co-Investigators, presence of medical complications that may interfere with the execution of the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• MetroHealth Center for Rehabilitation Research — Cleveland

Идентификаторы

NCT: NCT06836739 · STUDY00000717 · W81XWH2210778 - SC210121 · W81XWH2210781 - SC210121P1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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